Sickle Cell DiseaseHDL2NCT05780775
Lipid Balance in Adult Sickle Cell Patients
A study testing HDL2 in people with Sickle Cell Disease and Dyslipidemia, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
Trial summary
This study aims to describe and/or searches for, in cohorts of adult sickle cell anemia (SCA) and SC sickle cell patients living in the French West Indies and followed by SCD Reference and Competence Centers: 1-lipids profiles and associations at steady state with occurrence of sickle cell disease (SCD) complications… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease, Dyslipidemia, Complication
- What is being tested?
- HDL2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteGuadeloupe
- Study dates
- 30 Nov 2022to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged from 18 years and over
- Be affected with Sickle cell anemia or SC sickle cell
- Living in French Caribbean Islands of Guadeloupe or Martinique and followed by physicians issued from a French West Indies Sickle Cell Reference or Competence Center
- At steady state in the last month (without acute complication)
- To have given a written consent after information on the study.
Who cannot join
- Other hemoglobinopathies than sickle cell disease
- Pregnancy or lactation
- Patient under judicial protection or without freedom
- Patient not affiliated with a social security system
- Patient hospitalized for transfusion or bleeding in the last 3 months
Trial locations and contacts
1 site in 1 country.
Guadeloupe1 site
Unité Transversale de la Drépanocytose
Pointe-à-Pitre, 97159
About this study
Official title: Study of Lipid Balance in Adult Sickle Cell SS or SC Patients at Steady State and According to Clinical Phenotypes and During Acute Complications Acronym : "HDL2"
This study aims to describe and/or searches for, in cohorts of adult sickle cell anemia (SCA) and SC sickle cell patients living in the French West Indies and followed by SCD Reference and Competence Centers: 1-lipids profiles and associations at steady state with occurrence of sickle cell disease (SCD) complications, 2-lipids profile evolution during and after prospective acute complications (vasoocclusive crises (VOC) and priapism), 3-lipids profile variation (inter /intra individuals) during 4 prospective years, 4- Genetic primary modulators of SCD complications, 5- insulin resistance (HOMA), free fatty acids and glycerol dosages, 6- lipids enzymes, lipidome and functionality of HDL in sub-groups of SCD population.
Read the detailed description
- Cohorts of sickle cell disease patients including sickle cell anemia (SCA) and SC sickle cell patients living in Guadeloupe and Martinique and followed by the Sickle cell disease (SCD) Reference and Competence Centers of French West Indies.
- Lipid profile includes total cholesterol, HDL-cholesterol, non-HDL-cholesterol, LDL-cholesterol and triglycerides, apolipoprotein A-I and B.
Medical histories and prospective collection of SCD complications include retinopathy, deafness, tinnitus, osteonecrosis, leg ulcers, strokes, acute chest syndrome, VOC, priapism, pulmonary arterial hypertension (PAH) and PAH sd (echocardiography diagnosed when tricuspid regurgitant jet velocity ≥2.5 m/sec), kidney disease: chronic renal insufficiency and/or nephropathy.
- Objective 4: to describe genetic primary modulators of SCD complications: fetal hemoglobin, alpha-thalassemia, haplotypes of beta S gene.
- Objective 5 will be performed in the entire cohort at inclusion and during prospective complications (VOC, priapism).
- Objective 6 will be performed in a sub-group of 90 individuals (n=15 with VOC and n= 15 without VOC, n=15 with priapism and n=15 without priapism, n= 15 with pulmonary arterial hypertension syndrome (PAH Sd) and n=15 without PAH Sd), as well as in a subgroup of n = 15 patients prospectively experiencing VOC and n = 15 patients prospectively experiencing priapism.
A collection of plasma is performed to fulfill objective 6, as well as a collection of blood cells for later researches.
- Conditions
- Sickle Cell Disease, Dyslipidemia, Complication
- Being tested
- HDL2
- Keywords
- Sickle cell disease, lipids, vasoocclusive crisis, priapism, pulmonary arterial hypertension
- Medical subject headings
- Anemia, Sickle Cell, Dyslipidemias, Vaso-Occlusive Crises, Priapism, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDL2Other
Also called collection of plasma and of cells.
to perform additional blood samples during acute phase of complications (realized between Day 1 and Day 3) in SCD patients hospitalized for vasoocclusive crisis or priapism.
| Study group | Role | What they receive |
|---|---|---|
| HDL 2 follow up | Other | Cohort of adult sickle cell anemia (SCA) and SC sickle cell patients living in Guadeloupe and followed by SCD Reference and Competence Center of Guadeloupe. Receives: Other: HDL2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
/ Lipids profiles at steady state, in sickle cell anemia and SC sickle cell adult patients, classified according to occurrence of complications.
Cohorts of sickle cell disease patients include sickle cell anemia (SCA) and SC sickle cell patients living in Guadeloupe and Martinique and followed by the Sickle cell disease (SCD) Reference and Competence Centers of French West Indies.
Lipid profile includes total cholesterol, HDL-cholesterol, non-HDL-cholesterol, LDL-cholesterol and triglycerides, apolipoproteins A-I and B.
Collection of medical histories and of prospective SCD complications include retinopathy, deafness, tinnitus, osteonecrosis, leg ulcers, strokes, acute chest syndrome, VOC, priapism, pulmonary arterial hypertension (PAH) and PAH sd (echocardiography diagnosed when tricuspid regurgitant jet velocity ≥2.5 m/sec), kidney disease: chronic renal insufficiency and/or nephropathy
Measured: 6 years
Secondary outcomes (19)
Kinetic study of lipids profile during hospitalized vasoocclusive crisis (VOC, with or without ACS) and Priapism, at return to steady state at first annual check-up, and one year after this last measurement
Past and prospective collection of previously listed SCD complications
Measured: 6 years
Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.
total cholesterol
Measured: 6 years
Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.
HDL-cholesterol
Measured: 6 years
Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.
non HDL-cholesterol
Measured: 6 years
Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.
LDL-cholesterol
Measured: 6 years
Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.
triglycerides
Measured: 6 years
Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.
Apolipoproteins A-I and B
Measured: 6 years
Description of genetic primary modulators of SCD complications.
Fetal hemoglobin,
Measured: 6 years
Description of genetic primary modulators of SCD complications.
alpha-thalassemia,
Measured: 6 years
Description of genetic primary modulators of SCD complications.
haplotypes of beta S gene
Measured: 6 years
Dosages of Insulin resistance (HOMA),
Plasmatic insulinemia and glycemia (HOMA) will be performed in the entire cohort at inclusion and during prospective complications (VOC, priapism); lipids dosages
Measured: 6 years
free fatty acids
kinetic study of free fatty acids at inclusion and during prospective complications (VOC, priapism);
Measured: 6 years
plasmatic glycerol.
Kinetic study of plasmatic at inclusion and during prospective complications (VOC, priapism);
Measured: 6 years
Dosages of lipids enzymes, lipidome and functionality of HDL at steady state
The dosages of CETP (Cholesteryl Ester Transfer Protein) enzymes activities
Measured: 6 years
Dosages of lipids enzymes, lipidome and functionality of HDL at steady state
The dosages of L-CAT (Lécithine Cholestérol Acyl Transférase) enzymes activities
Measured: 6 years
Dosages of lipids enzymes, lipidome and functionality of HDL at steady state
The dosages of HDL lipidome,
Measured: 6 years
Dosages of lipids enzymes, lipidome and functionality of HDL at steady state
The dosages of HDL functionality,
Measured: 6 years
Dosages of lipids enzymes, lipidome and functionality of HDL at steady state
The dosages of free fatty acid
Measured: 6 years
Dosages of lipids enzymes, lipidome and functionality of HDL at steady state
The dosages of glycerol
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start30 Nov 2022
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Responsible party
- Sponsor
- Investigators
- Marie-Laure LALANNE-MISTRIH, Principal investigator, : University Hospital of Guadeloupe - Department of Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780775
- Sponsor's protocol ID
- PAP_RIPH2_2021/09
- Acronym
- HDL2
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2022
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Lipid Balance in Adult Sickle Cell SS or SC Patients at Steady State and According to Clinical Phenotypes and During Acute Complications Acronym : "HDL2"
- ClinicalTrials.gov ID
- NCT05780775
- Acronym / sponsor ID
- HDL2 / PAP_RIPH2_2021/09
- Conditions
- Sickle Cell Disease, Dyslipidemia, Complication
- Keywords
- Sickle cell disease, lipids, vasoocclusive crisis, priapism, pulmonary arterial hypertension
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to describe and/or searches for, in cohorts of adult sickle cell anemia (SCA) and SC sickle cell patients living in the French West Indies and followed by SCD Reference and Competence Centers: 1-lipids profiles and associations at steady state with occurrence of sickle cell disease (SCD) complications, 2-lipids profile evolution during and after prospective acute complications (vasoocclusive crises (VOC) and priapism), 3-lipids profile variation (inter /intra individuals) during 4 prospective years, 4- Genetic primary modulators of SCD complications, 5- insulin resistance (HOMA), free fatty acids and glycerol dosages, 6- lipids enzymes, lipidome and functionality of HDL in sub-groups of SCD population.
Detailed description
- Cohorts of sickle cell disease patients including sickle cell anemia (SCA) and SC sickle cell patients living in Guadeloupe and Martinique and followed by the Sickle cell disease (SCD) Reference and Competence Centers of French West Indies.
- Lipid profile includes total cholesterol, HDL-cholesterol, non-HDL-cholesterol, LDL-cholesterol and triglycerides, apolipoprotein A-I and B.
Medical histories and prospective collection of SCD complications include retinopathy, deafness, tinnitus, osteonecrosis, leg ulcers, strokes, acute chest syndrome, VOC, priapism, pulmonary arterial hypertension (PAH) and PAH sd (echocardiography diagnosed when tricuspid regurgitant jet velocity ≥2.5 m/sec), kidney disease: chronic renal insufficiency and/or nephropathy.
- Objective 4: to describe genetic primary modulators of SCD complications: fetal hemoglobin, alpha-thalassemia, haplotypes of beta S gene.
- Objective 5 will be performed in the entire cohort at inclusion and during prospective complications (VOC, priapism).
- Objective 6 will be performed in a sub-group of 90 individuals (n=15 with VOC and n= 15 without VOC, n=15 with priapism and n=15 without priapism, n= 15 with pulmonary arterial hypertension syndrome (PAH Sd) and n=15 without PAH Sd), as well as in a subgroup of n = 15 patients prospectively experiencing VOC and n = 15 patients prospectively experiencing priapism.
A collection of plasma is performed to fulfill objective 6, as well as a collection of blood cells for later researches.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HDL 2 follow up | Other | Other: HDL2Cohort of adult sickle cell anemia (SCA) and SC sickle cell patients living in Guadeloupe and followed by SCD Reference and Competence Center of Guadeloupe. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged from 18 years and over
- Be affected with Sickle cell anemia or SC sickle cell
- Living in French Caribbean Islands of Guadeloupe or Martinique and followed by physicians issued from a French West Indies Sickle Cell Reference or Competence Center
- At steady state in the last month (without acute complication)
- To have given a written consent after information on the study.
Key exclusion criteria (5 listed)
- Other hemoglobinopathies than sickle cell disease
- Pregnancy or lactation
- Patient under judicial protection or without freedom
- Patient not affiliated with a social security system
- Patient hospitalized for transfusion or bleeding in the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDL2Also: collection of plasma and of cells.to perform additional blood samples during acute phase of complications (realized between Day 1 and Day 3) in SCD patients hospitalized for vasoocclusive crisis or priapism. | Other | HDL 2 follow up |
Primary outcome
/ Lipids profiles at steady state, in sickle cell anemia and SC sickle cell adult patients, classified according to occurrence of complications.
Time frame: 6 years
Cohorts of sickle cell disease patients include sickle cell anemia (SCA) and SC sickle cell patients living in Guadeloupe and Martinique and followed by the Sickle cell disease (SCD) Reference and Competence Centers of French West Indies. Lipid profile includes total cholesterol, HDL-cholesterol, non-HDL-cholesterol, LDL-cholesterol and triglycerides, apolipoproteins A-I and B. Collection of medical histories and of prospective SCD complications include retinopathy, deafness, tinnitus, osteonecrosis, leg ulcers, strokes, acute chest syndrome, VOC, priapism, pulmonary arterial hypertension (PAH) and PAH sd (echocardiography diagnosed when tricuspid regurgitant jet velocity ≥2.5 m/sec), kidney disease: chronic renal insufficiency and/or nephropathy
19 secondary outcomes
Kinetic study of lipids profile during hospitalized vasoocclusive crisis (VOC, with or without ACS) and Priapism, at return to steady state at first annual check-up, and one year after this last measurement
Time frame: 6 years
Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.
Time frame: 6 years
Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.
Time frame: 6 years
Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.
Time frame: 6 years
Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.
Time frame: 6 years
Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.
Time frame: 6 years
Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.
Time frame: 6 years
Description of genetic primary modulators of SCD complications.
Time frame: 6 years
Description of genetic primary modulators of SCD complications.
Time frame: 6 years
Description of genetic primary modulators of SCD complications.
Time frame: 6 years
Dosages of Insulin resistance (HOMA),
Time frame: 6 years
free fatty acids
Time frame: 6 years
plasmatic glycerol.
Time frame: 6 years
Dosages of lipids enzymes, lipidome and functionality of HDL at steady state
Time frame: 6 years
Dosages of lipids enzymes, lipidome and functionality of HDL at steady state
Time frame: 6 years
Dosages of lipids enzymes, lipidome and functionality of HDL at steady state
Time frame: 6 years
Dosages of lipids enzymes, lipidome and functionality of HDL at steady state
Time frame: 6 years
Dosages of lipids enzymes, lipidome and functionality of HDL at steady state
Time frame: 6 years
Dosages of lipids enzymes, lipidome and functionality of HDL at steady state
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Laure LALANNE-MISTRIH principal investigator
: University Hospital of Guadeloupe - Department of Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HDL2 in people with Sickle Cell Disease and Dyslipidemia, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guadeloupe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
/ Lipids profiles at steady state, in sickle cell anemia and SC sickle cell adult patients, classified according to occurrence of complications. (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.